Fecobionics Device for Chronic Constipation

Recruiting at 2 trial locations

Overseen By Hans Gregersen,, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The California Medical Innovations Institute, Inc.

Must not be taking: Anorectal function medications

Disqualifiers: Pregnancy, Fecal incontinence, Chronic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand and improve treatments for chronic constipation, a common issue affecting many people. Researchers will use a device called Fecobionics, which mimics natural stool, to study how the body moves and expels waste. The trial will test two treatments: atropine, which may slow bowel movements, and bisacodyl, which may speed them up. Individuals with a regular bowel pattern or those experiencing constipation symptoms like infrequent bowel movements or straining may be suitable for this study. Participants will contribute to insights that could lead to better treatments for constipation. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve future constipation treatments.

Do I have to stop taking my current medications for the trial?

Yes, if you are taking medications that affect anorectal function, you cannot participate in the trial.

What prior data suggests that the Fecobionics device is safe for studying chronic constipation?

Research has shown that the Fecobionics device is safe. This new, low-risk tool is less invasive and designed to mimic natural bowel movements. The device does not use radiation and enhances understanding of bowel function. No reports have linked harmful effects directly to Fecobionics.

The trial includes two treatment groups using well-known medications: atropine and bisacodyl. Atropine may cause mild side effects such as dry mouth and blurred vision. Bisacodyl, a laxative, can cause stomach discomfort in some individuals but is usually well-tolerated. Both drugs are commonly used in medical practice, supporting their general safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fecobionics device because it offers a novel way to evaluate and potentially treat chronic constipation by simulating natural bowel movements. Unlike traditional treatments like fiber supplements, laxatives, or enemas, Fecobionics uses a high-tech, balloon-based method to mimic the rectum's natural processes. This device provides detailed data on how the bowel functions during defecation, which could lead to more personalized and effective constipation treatments. Additionally, by studying the effects of drugs like atropine and bisacodyl on this device, researchers hope to gain insights into how these medications influence bowel movements, potentially leading to optimized therapeutic strategies.

What evidence suggests that the Fecobionics device is effective for chronic constipation?

Research has shown that biofeedback, a technique similar to what Fecobionics aims to achieve, successfully treats chronic constipation. Studies indicate that over 70% of patients with pelvic floor problems benefit from biofeedback therapy, which improves muscle coordination and bowel movements. In this trial, the Fecobionics device mimics natural stool to observe the body's response during bowel movements. This method could offer new insights into bodily functions during these processes, potentially leading to better treatments. The device's ability to measure various physical changes might enhance understanding and treatment of constipation. Researchers will study participants with and without the use of atropine or bisacodyl to assess their effects on defecation. ^{1 5 6 7 8}

Who Is on the Research Team?

Hans Gregersen, MD, PhD

Principal Investigator

California Medical Innovations Institute

Are You a Good Fit for This Trial?

This trial is for adults with normal bowel movements or those meeting the Rome IV criteria for chronic constipation, which includes symptoms like infrequent bowel movements and difficulty during defecation. Excluded are pregnant women, individuals unwilling to consent to tests, those with fecal incontinence, significant chronic diseases, medication affecting anorectal function, or a history of relevant surgeries.

Inclusion Criteria

I have chronic constipation based on specific symptoms I've had for the last 3 months.

I have regular bowel movements without difficulty.

Exclusion Criteria

I am not pregnant, willing to undergo specific tests, and have no history of bowel surgery.

Normal subjects: Subjects not willing to consent and undergo the specified tests in this study, Pregnant women, Subjects with concurrent fecal incontinence and constipation symptoms, Chronic diseases, Taking medications that affect anorectal function, History of anorectal surgery or bowel resection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Testing

Participants undergo Fecobionics testing to study defecation dynamics and patterns using various interventions such as atropine and bisacodyl.

3-4 weeks

Multiple visits for testing and intervention administration

Follow-up

Participants are monitored for safety and effectiveness after experimental testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fecobionics

Trial Overview The study is testing how well a new device called Fecobionics can mimic and measure the natural process of defecation by recording various parameters in both healthy subjects and patients with chronic constipation. It aims to improve understanding of normal and abnormal defecatory patterns without using invasive methods or radiation.

How Is the Trial Designed?

Group I: Effect of bisacodyl on the defecation Experimental Treatment 1 Intervention

Bisacodyl is a stimulant of rectal contraction and expected to facilitate evacuation of rectal balloon (fecobionics device). Each subject will be studied twice, once with and once without bisacodyl.

Group II: Effect of atropine on the defecation Experimental Treatment 1 Intervention

Atropine is an anticholinergic drug and expected to inhibit rectal contractions and inhibit evacuation of the rectal balloon. Each subject will be studied twice once with and once without atropine.

Who Is Running the Clinical Trial?

The California Medical Innovations Institute, Inc.

Lead Sponsor

Trials

4

Recruited

790+

Augusta University

Collaborator

Trials

219

Recruited

85,900+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Pelvic floor biofeedback therapy is a safe and effective treatment for conditions like chronic constipation, urinary incontinence, fecal incontinence, and pelvic floor pain, particularly for patients without severe pelvic organ prolapse or neurogenic defects.

The therapy's success is enhanced when patients have good mental cognition and adhere to treatment, with training focusing on muscle targeting, coordination, and strength, and its effectiveness evaluated through various symptoms and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. Ding, S.[2018]

In a study of 70 patients with chronic constipation undergoing biofeedback therapy, those with higher depression scores and lower rectal sensation thresholds showed poorer responses to the treatment.

Improving the psychological state and addressing rectal sensitivity in these patients could enhance the effectiveness of biofeedback therapy for chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Predictors of efficacy of biofeedback therapy in patients with chronic constipation]. Li, M., Ye, B., Tang, Y., et al.[2014]

Biofeedback therapy is an effective treatment for defecatory disorders, showing response rates of approximately 70-80% for dyssynergic defecation and 76% for fecal incontinence in randomized controlled trials, indicating its efficacy in improving pelvic floor muscle coordination and rectal sensation.

This therapy is safe and can lead to lasting improvements even after the treatment ends, but further research is needed to establish standardized protocols for its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of functional and motility test: how to perform biofeedback for constipation and fecal incontinence. Lee, HJ., Jung, KW., Myung, SJ.[2021]

A biofeedback training program significantly reduced inappropriate pelvic floor muscle contractions in 15 subjects with chronic constipation, leading to a 69.9% decrease in the anismus index after an average of 3.1 weeks of treatment.

Patients experienced improved defecation frequency and ease, with lasting benefits observed for up to 6.2 months post-treatment, as shown by changes in anorectal angles during defecation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. Kawimbe, BM., Papachrysostomou, M., Binnie, NR., et al.[2019]

In a study of 130 patients undergoing biofeedback therapy (BFT) for chronic constipation (CC) and fecal incontinence (FI), the overall response rate was 76.2%, indicating that BFT is effective in clinical practice, similar to previous clinical trials.

Patients with fecal incontinence had a higher response rate (79.6%) and symptom improvement (67.3%) compared to those with chronic constipation and dyssynergic defecation, who had a lower response rate of 69.8% and only 45.3% showed symptomatic improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Biofeedback Therapy in Clinical Practice for the Management of Chronic Constipation and Fecal Incontinence. Parker, CH., Henry, S., Liu, LWC.[2023]

Biofeedback is the preferred treatment for many common types of fecal incontinence and shows promise for treating constipation caused by pelvic floor muscle dysfunction, which affects up to 50% of chronic constipation patients.

Thermal biofeedback is effective as part of a comprehensive behavioral treatment for irritable bowel syndrome, and further research is exploring additional applications of biofeedback in gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatment of gastrointestinal disorders. Whitehead, WE.[2019]

A new home-based biofeedback device for fecal incontinence was tested in a pilot study with ten patients, showing significant improvements in anal continence both clinically and through manometric measurements.

This device may enhance patient compliance and reduce the need for hospital visits during treatment, offering a promising alternative to traditional biofeedback therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Controlled Biofeedback Device for the Treatment of Fecal Incontinence: A Pilot Study. Damin, DC., Hommerding, F., Schirmer, D., et al.[2018]

An abbreviated anorectal biofeedback (BF) protocol was found to be as effective as the standard BF protocol in improving symptoms of chronic constipation and fecal incontinence in a study of 93 patients (31 in the abbreviated group and 62 in the standard group).

While both protocols improved quality of life and patient satisfaction, the standard BF protocol resulted in greater satisfaction and better rectal sensation, suggesting that while the abbreviated protocol is effective, further refinement of BF methods could enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anorectal biofeedback: an effective therapy, but can we shorten the course to improve access to treatment? Mazor, Y., Kellow, JE., Prott, GM., et al.[2023]

In a case series conducted at a tertiary care center, 92% of patients with fecal incontinence and 80% of patients with constipation experienced significant improvement after undergoing electromyogram-guided biofeedback retraining of the pelvic floor.

Despite the high rates of improvement in symptoms, there were no significant changes in electromyographic values, suggesting that biofeedback may help manage symptoms through mechanisms other than direct changes in pelvic floor muscle activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback is effective therapy for fecal incontinence and constipation. Ko, CY., Tong, J., Lehman, RE., et al.[2022]

In a study of 75 participants with fecal incontinence, supplementary home-based biofeedback using a Peritron perineometer significantly improved quality of life, particularly in younger individuals, compared to standard biofeedback alone.

While overall clinical improvements were limited, younger participants showed notable enhancements in continence and quality of life, indicating that home biofeedback can be a beneficial self-management tool for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. Bartlett, L., Sloots, K., Nowak, M., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC341393/

Biofeedback for pelvic floor dysfunction in constipation - PMC Literature reviews conclude that more than 70% of adult patients complaining of pelvic floor dyssynergia are likely to benefit from biofeedback training, and so ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7843943/

Biofeedback for Pelvic Floor Disorders - PMC Biofeedback has demonstrated efficacy in the treatment of chronic constipation with dyssynergic defecation, fecal incontinence, and low anterior resection ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S209050681400058X

Efficacy of biofeedback-assisted pelvic floor muscle ... A Significant improvement was detected in 19 females (79.2%) in the intervention group compared to 7 females (31.8%) in the control group.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.70084

Efficacy of Biofeedback Therapy on Chronic Constipation ... Studies have shown that biofeedback therapy significantly reduces constipation symptoms by improving muscle coordination and bowel movements [7] ...

5. ageb.be ageb.be/Articles/Volume%2084%20(2021)/Fasc4/08-Ozturk.pdf

Efficacy of combination of biofeedback therapy and pelvic floor ... A combination of abdominal and pelvic floor muscle exercises and BFT increased patient response. Different types of studies in the literature report varying ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6891014/

Systematic review: Pelvic floor muscle training for ... Pelvic floor muscle training appears to be of therapeutic value in some patients with quiescent IBD and evacuation difficulty or fecal incontinence.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016508505022742

Biofeedback Is Superior to Laxatives for Normal Transit ... Background & Aims: Uncontrolled trials suggest biofeedback is an effective treatment for pelvic floor dyssynergia (PFD), a type of constipation defined by ...

8. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/unique-intensive-curriculum-helps-patients-retrain-pelvic-floor-muscles/mac-20506013

Unique, intensive curriculum helps patients retrain pelvic ... The program's intensive curriculum involves retraining the pelvic floor muscles using biofeedback training and behavior modification.